A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
Locations
United States
Texas
ICON Early Phase
RECRUITING
San Antonio
Contact Information
Primary
Enanta Pharmaceuticals, Inc
emartin@enanta.com
(617) 607-0800
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 98
Treatments
Experimental: EDP-978 SAD Cohorts
EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration
Experimental: EDP-978 MAD Cohorts
EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days
Placebo_comparator: EDP-978 SAD Placebo Cohorts
Matching placebo, orally, once daily in one single administration
Placebo_comparator: EDP-978 MAD Placebo Cohorts
Matching placebo, orally, once daily for 14 days
Related Therapeutic Areas
Sponsors
Leads: Enanta Pharmaceuticals, Inc